SOP-13 Improvement (Corrective - Preventive Action)

STANDARD OPERATING PROCEDURES
FOR
IMPROVEMENT (CORRECTIVE/PREVENTIVE ACTION)
QUALITY PROCEDURE
CORRECTIVE / PREVENTIVE ACTION

(IMPROVEMENT)
Issue No. :
Issue Date :
Rev. No.
:
Owner: M R
01
December 15th 2009
00
Authorized by: C E
Page 94

FOR
DISTRIBUTION LIST
Copy No.
Owner: M R
Issued to (Designation)
Authorized by: C E
Page 95

FOR
AMENDMENT SHEET
Revision
No.
Date
Owner: M R
Issue No.
Page No
Authorized by: C E
Nature of
Amendment
Approved by
Page 96

FOR
1. Purpose
To provide a system for continual improvement in the quality
management system by implementing Corrective and Preventive
Action.
2. Scope
This procedure is applicable to all functions in the Company who
can suggest and implement corrective and preventive action for
improvement in the management system.
3. Responsibilities
The Company personnel are encouraged to identify and
bring into notice of their supervisor an area for improvement
in the quality management system.
The section Incharge or departmental head can initiate the
corrective and preventive action by filling in the Corrective/
Preventive Action Request (CPAR) describing the
unsatisfactory condition or the improvement suggestion.
MR is responsible for maintaining the Corrective Preventive
Action Log.
The concerned departmental head is responsible for
implementing the corrective and preventive action related to
his department with in the specified timeframe.
M.R is responsible for the follow up of corrective and
preventive action.
4. Procedures
Step I.
Owner: M R
Continual Improvement
The Company personnel are encouraged to identify
opportunities in the quality management system related
to his work function. The improvements may be
identified in the following manner:
a) Progressive up-grading the quality objectives on
routine basis
b) Performance improvements
c) Initiating corrective actions on recurrent problems
d) Initiating preventive actions on potential nonconformities
e) Giving suggestions for improvement
f) Quality Circles.
Authorized by: C E
Page 97

FOR
Step II.
Initiating Corrective Actions

Corrective actions are taken to eliminate the causes
of non-conformities to prevent their recurrence.
Corrective Actions may be initiated in the following
cases:
Identification of major product non-conformity or
recurrent problems
Any non-compliance identified during an internal
or external quality audit
Customer feedback including customer complaints
Non-conforming deliveries from suppliers.
Step III.
Requesting and processing CPAR

Corrective actions can be initiated by any person
in the Company by reporting it to his section Incharge or
departmental head. The concerned section in-charge or
departmental head fills in the Corrective / Preventive
Action Request (CPAR). The request contains a
description of the unsatisfactory condition that needs to
be corrected and are addressed to the manager who is
responsible for the area where condition occurred.
The CPAR is sent to M.R who reviews the
corrective action with concerned departmental head.
After approval by departmental head, the responsible
person and target date for implementing the corrective
actions are assigned.
The responsible person investigates the causes of
the problem that initiated the request. The investigation
process includes.
Interviewing the concerned persons and gathering
their views about the possible causes of nonconformities.
Observing and examining the concerned processes
and related records
Examining the supplier and his supplies, if required
If appropriate, make use of statistical techniques
( cause and effect diagram) to determine root causes
He then proposes a corrective action to be taken and
indicates the date by which the corrective action will be
fully implemented.
Owner: M R
Authorized by: C E
Page 98

FOR
Step IV.
Implementation of Corrective Action

When a corrective and preventive action is decided
upon, it is implemented on trial basis and the results are
closely monitored. Further measures or changes in the
measures may have to be made during the trial period
until satisfactory results are attained. The magnitude of
corrective action depends on the nature of nonconformity and its effect on the quality of product.
Step V.
Verification of Corrective Action

On, or immediately after, the due date of
implementation of a corrective action, M.R follow up to
determine if the corrective action has been implemented
and if it is effective. When there is objective evidence
that the corrective action is effective, the CPAR can be
closed out. If more work is needed to fully implement the
action, a new follow up date is agreed upon
When the corrective and preventive measures are
found to be effective, they are incorporated in the quality
system by making suitable changes in the relevant
documents such as drawings, specifications, operating
procedures, work instructions and quality system
procedures.
Step VI.
Preventive Actions
Preventive actions are taken to eliminate any
potential causes of non-conformity. The objective is to
provide a mean for detecting any deterioration in
processes, work standards and systems and thus to
prevent the occurrence of a non-conformity.
The need for preventive action is brought out by analysis
of the following information:
Data on product and process trends
Customer feedback
Inspection and test records
Performance reviews of suppliers
Step VII.
Implementation of Corrective Action

When a corrective and preventive action is decided
upon, it is implemented on trial basis and the results are
closely monitored. Further measures or changes in the
measures may have to be made during the trial period
until satisfactory results are attained. The magnitude of
Owner: M R
Authorized by: C E
Page 99

FOR
corrective action depends on the nature of nonconformity and its effect on the quality of product
A preventive action can also be initiated by any
person by reporting it to his/ her section in-charge or
departmental head that fills in the CPAR and sends it to
MR.
Step VIII.
Suggestions from Employees

All employees are encouraged to make suggestions
or recommendations for improvement in quality
management system.
Any person can give suggestion by filling in the
prescribed Suggestion Form, available in all section. The
suggestion from signed by the suggestor and the
concerned section in-charge. The Suggestion from is
submitted to the concerned departmental head who
reviews and approves the suggestion. In case the
suggestion is rejected, the reason for its rejection is given
on the suggestion from and the suggestor is informed by
the concerned section in-charge. In case the suggestion is
approved, it is intimated to the ISO Coordinator who logs
the suggestion in the Suggestion Log.
After Approval of suggestion, the concerned
departmental heads assigns the responsible person and
target date for implementation of suggestion.
Step IX.
Management Review Meetings

Status of corrective and preventive actions is
presented in management review meetings as input.
RELATED DOCUMENTS
Procedure for Management Review
Procedure for Internal Quality Audit
RELATED RECORDS
Corrective / Preventive Action Request
Corrective Action Log
Suggestion Form
Suggestion Log
Quality Report / Test Report.
Owner: M R
Authorized by: C E
Page 100

FOR
F-13
Serial No: _______

Date: ___________
CORRECTIVE / PREVENTIVE ACTION FORM

Person / Organisation Name: .
Nonconformance Description: .
Investigation/ Root Cause:
Signature officer;
Incharge Signature:
Corrective / Preventive Action: .
Signature officer;
Incharge Signature:
Follow Up Action: .
Signature officer;
Owner: M R
Incharge Signature:
Authorized by: C E
Page 101

FOR
MR: __________
Owner: M R
GM: __________
Authorized by: C E
CE: __________
Page 102

SOP-13 Improvement (Corrective - Preventive Action)

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STANDARD OPERATING PROCEDURES

CORRECTIVE / PREVENTIVE ACTION

STANDARD OPERATING PROCEDURES

STANDARD OPERATING PROCEDURES

STANDARD OPERATING PROCEDURES

STANDARD OPERATING PROCEDURES

Initiating Corrective Actions

Requesting and processing CPAR

STANDARD OPERATING PROCEDURES

Implementation of Corrective Action

Verification of Corrective Action

Implementation of Corrective Action

STANDARD OPERATING PROCEDURES

Suggestions from Employees

Management Review Meetings

STANDARD OPERATING PROCEDURES

Serial No: _______

CORRECTIVE / PREVENTIVE ACTION FORM

Investigation/ Root Cause:

Corrective / Preventive Action: .

STANDARD OPERATING PROCEDURES

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